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Abstract：
BACKGROUND: Randomised trials are essential to reliably assess medical interventions. Nevertheless, interpretation of such studies, particularly when considering absolute effects, is enhanced by understanding how the trial population may differ from the populations it aims to represent.
METHODS: We compared baseline characteristics and mortality of RECOVERY participants recruited in England (n = 38,510) with a reference population hospitalised with COVID-19 in England (n = 346,271) from March 2020 to November 2021. We used linked hospitalisation and mortality data for both cohorts to extract demographics, comorbidity/frailty scores, and crude and age- and sex-adjusted 28-day all-cause mortality.
RESULTS: Demographics of RECOVERY participants were broadly similar to the reference population, but RECOVERY participants were younger (mean age [standard deviation]: RECOVERY 62.6 [15.3] vs reference 65.7 [18.5] years) and less frequently female (37% vs 45%). Comorbidity and frailty scores were lower in RECOVERY, but differences were attenuated after age stratification. Age- and sex-adjusted 28-day mortality declined over time but was similar between cohorts across the study period (RECOVERY 23.7% [95% confidence interval: 23.3-24.1%]; vs reference 24.8% [24.6-25.0%]), except during the first pandemic wave in the UK (March-May 2020) when adjusted mortality was lower in RECOVERY.
CONCLUSIONS: Adjusted 28-day mortality in RECOVERY was similar to a nationwide reference population of patients admitted with COVID-19 in England during the same period but varied substantially over time in both cohorts. Therefore, the absolute effect estimates from RECOVERY were broadly applicable to the target population at the time but should be interpreted in the light of current mortality estimates.
BACKGROUND: ISRCTN50189673- Feb. 04, 2020, NCT04381936- May 11, 2020.
METHODS: We compared baseline characteristics and mortality of RECOVERY participants recruited in England (n = 38,510) with a reference population hospitalised with COVID-19 in England (n = 346,271) from March 2020 to November 2021. We used linked hospitalisation and mortality data for both cohorts to extract demographics, comorbidity/frailty scores, and crude and age- and sex-adjusted 28-day all-cause mortality.
RESULTS: Demographics of RECOVERY participants were broadly similar to the reference population, but RECOVERY participants were younger (mean age [standard deviation]: RECOVERY 62.6 [15.3] vs reference 65.7 [18.5] years) and less frequently female (37% vs 45%). Comorbidity and frailty scores were lower in RECOVERY, but differences were attenuated after age stratification. Age- and sex-adjusted 28-day mortality declined over time but was similar between cohorts across the study period (RECOVERY 23.7% [95% confidence interval: 23.3-24.1%]; vs reference 24.8% [24.6-25.0%]), except during the first pandemic wave in the UK (March-May 2020) when adjusted mortality was lower in RECOVERY.
CONCLUSIONS: Adjusted 28-day mortality in RECOVERY was similar to a nationwide reference population of patients admitted with COVID-19 in England during the same period but varied substantially over time in both cohorts. Therefore, the absolute effect estimates from RECOVERY were broadly applicable to the target population at the time but should be interpreted in the light of current mortality estimates.
BACKGROUND: ISRCTN50189673- Feb. 04, 2020, NCT04381936- May 11, 2020.
摘要：
背景：随机试验对于可靠地评估医疗干预措施至关重要。然而，对此类研究的解释，特别是当考虑绝对效应时，通过了解试验人群可能与它旨在代表的人群之间的差异来增强。
方法：我们比较了2020年3月至2021年11月在英格兰招募的RECOVERY参与者（n=38,510）与在英格兰住院的COVID-19参考人群（n=346,271）的基线特征和死亡率。我们使用两个队列的相关住院和死亡率数据来提取人口统计数据，合并症/虚弱评分，以及粗略的年龄和性别调整后的28天全因死亡率。
结果：恢复参与者的人口统计学特征与参考人群大致相似，但康复参与者年龄较小(平均年龄[标准差]:康复62.6[15.3]岁vs参考65.7[18.5]岁),女性频率较低(37%vs45%).合并症和虚弱评分在恢复方面较低，但年龄分层后差异减弱。年龄和性别调整后的28天死亡率随着时间的推移而下降，但在整个研究期间，队列之间相似(恢复23.7%[95%置信区间：23.3-24.1%];与参考24.8%[24.6-25.0%])，除了在英国的第一次大流行浪潮(2020年3月至5月)期间，调整后的死亡率在恢复方面较低。
结论：恢复中调整后的28天死亡率与同期英格兰收治的COVID-19患者的全国参考人群相似，但两个队列随时间变化很大。因此,RECOVERY的绝对效应估计值在当时广泛适用于目标人群,但应根据当前的死亡率估计值进行解释.
背景：ISRCTN50189673-2月2020年4月4日，NCT04381936-2020年5月11日。
方法：我们比较了2020年3月至2021年11月在英格兰招募的RECOVERY参与者（n=38,510）与在英格兰住院的COVID-19参考人群（n=346,271）的基线特征和死亡率。我们使用两个队列的相关住院和死亡率数据来提取人口统计数据，合并症/虚弱评分，以及粗略的年龄和性别调整后的28天全因死亡率。
结果：恢复参与者的人口统计学特征与参考人群大致相似，但康复参与者年龄较小(平均年龄[标准差]:康复62.6[15.3]岁vs参考65.7[18.5]岁),女性频率较低(37%vs45%).合并症和虚弱评分在恢复方面较低，但年龄分层后差异减弱。年龄和性别调整后的28天死亡率随着时间的推移而下降，但在整个研究期间，队列之间相似(恢复23.7%[95%置信区间：23.3-24.1%];与参考24.8%[24.6-25.0%])，除了在英国的第一次大流行浪潮(2020年3月至5月)期间，调整后的死亡率在恢复方面较低。
结论：恢复中调整后的28天死亡率与同期英格兰收治的COVID-19患者的全国参考人群相似，但两个队列随时间变化很大。因此,RECOVERY的绝对效应估计值在当时广泛适用于目标人群,但应根据当前的死亡率估计值进行解释.
背景：ISRCTN50189673-2月2020年4月4日，NCT04381936-2020年5月11日。
